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DOP024. Pregnancy outcomes after exposure to certolizumab pegol: Results from safety surveillance

U. Mahadevan1, S. Vermeire2, D.C. Wolf3, F. Forger4, J.J. Cush5, A. Golembesky6, L. Shaughnessy6, D. De Cuyper7, S. Abbas8, M.E.B. Clowse9, 1UCSF Medical Center, San Francisco, United States, 2University Hospital Gasthuisberg, Division of Gastroenterology, Leuven, Belgium, 3Atlanta Gastroenterology Associates, Atlanta, United States, 4University of Bern, Department of Rheumatology and Clinical Immunology and Allergology, Bern, Switzerland, 5Baylor Research Institute and Baylor University Medical Center, Dallas, United States, 6UCB Pharma, Raleigh, United States, 7UCB Pharma, Brussels, Belgium, 8UCB Pharma, Paris, France, 9Duke University Medical Center, Rheumatology, Durham, United States

Background

Certolizumab pegol (CZP) is a PEGylated Fc-free anti-TNF approved in 45 countries for the treatment of rheumatoid arthritis (RA) and/or Crohn's disease (CD); it was recently approved for psoriatic arthritis and axial spondyloarthritis. Prior analysis of pregnancy data from the UCB Pharma global safety database through 06 March 2012 have been published previously [1]. This is an updated analysis of pregnancy outcomes after CZP exposure from the database including new reports and ongoing pregnancies.

Methods

The UCB Pharma global safety database, designed to house and report adverse events for UCB Pharma products, was searched for all medically confirmed cases of pregnancy through 28 March 2013. Reported pregnancies include women who become pregnant while participating in a clinical study and spontaneous post-marketing reports. The number of live births, spontaneous miscarriages and elective terminations for neonates exposed to CZP (maternal and paternal exposure) was examined. Congenital abnormalities, neonatal deaths and maternal demographics were also investigated.

Results

As of 28 March 2013, 309 CZP exposed pregnancies were reported, 285 were maternal exposure and 24 were paternal. For pregnancies with maternal exposure, the major underlying condition was CD (190/285; 67%). Pregnancy outcomes were available for 190 of these 285 pregnancies: 124 in women with CD and 66 in women with other indications. For the 124 pregnancies in women with CD with known outcomes, 91 (73%) resulted in live birth, 25 (20%) in spontaneous miscarriage and 8 (7%) in elective termination. Table 1 presents characteristics for pregnancies in women with CD and for all reported pregnancies. Four congenital anomalies were reported among all live births with maternal CZP exposure (n = 132): vesicoureteric reflux, congenital morbus, hirschsprung disease and club foot, high aortic arch with aberrant left subclavian artery, and mild unilateral hydronephrosis on antenatal ultrasound, described as healthy upon birth. None of these events were considered related to CZP by the treating physicians. A single neonatal death was reported after maternal exposure in one of a set of twins delivered before 26 weeks of gestation.

Table 1. Pregnancy outcomes and maternal/neonatal characteristics
Parametern (%)
CD (N = 190)All (N = 285)
Known pregnancy outcome124190
 Live birth91 (73.4%)132 (69.5%)
 Spontaneous abortion25 (20.2%)36 (18.9%)
 Elective termination8 (6.5%)22 (11.6%)
Maternal age at delivery 1
 Number with available data71101
 Mean (SD)30.3 (4.96)30.5 (5.10)
 Median29.329.8
 Min, Max21.7, 42.921.5, 42.9
Gestational age at outcome 2
 Number with available data5077
 Mean (SD)38.4 (2.02)38.3 (1.97)
 Median39.039.0
 Min, Max32.0, 41.732.0, 41.7
Prematurity 2
 Number with available data5686
 <32 weeks1 (1.8%)1 (1.2%)
 32–36 weeks6 (10.7%)10 (11.6%)
 ≥37 weeks49 (87.5%)75 (87.2%)
Baby weight (g) 3
 Number with available data4162
 Mean (SD)3222.6 (429.87)3194.3 (447.84)
 Median3230.03215.0
 Min, Max2100.0, 4100.02100.0, 4535.9
Low birth weight 3
 1500–2499 g2 (4.9%)2 (3.2%)
 ≥2500 g39 (95.1%)60 (96.8%)
1 Analysis restricted to live births; 2 Analysis restricted to singleton live births; 3 Analyses restricted to singleton, term, live births.

Conclusion

Updated analysis of pregnancy outcomes after exposure to CZP supports previous reports suggesting no apparent impact of maternal CZP exposure on pregnancy outcomes. Additional prospective data are required to fully evaluate the safety and tolerability of CZP in pregnancy.

1. Clowse M. Arthritis Rheum 2012; 64(Suppl 10): S702.